Clearance Summary
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU received FDA 510(k) clearance under submission number K130653, sponsored by Ethicon Endo-Surgery, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-03-29.
- Submission: K130653
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2013-03-29
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.